Abstract：
BACKGROUND:Extended-release naltrexone (XR-NTX, Vivitrol; Alkermes Inc.) is an injectable monthly sustained-release mu opioid receptor antagonist. XR-NTX is a potentially effective intervention for opioid use disorders and as relapse prevention among criminal justice system (CJS) populations. METHODS:This 5-site open-label randomized controlled effectiveness trial examines whether XR-NTX reduces opioid relapse compared with treatment as usual (TAU) among community dwelling, non-incarcerated volunteers with current or recent CJS involvement. The XR-NTX arm receives 6 monthly XR-NTX injections at Medical Management visits; the TAU group receives referrals to available community treatment options. Assessments occur every 2 weeks during a 24-week treatment phase and at 12- and 18-month follow-ups. The primary outcome is a relapse event, defined as either self-report or urine toxicology evidence of ≥10 days of opioid use in a 28-day (4 week) period, with a positive or missing urine test counted as 5 days of opioid use. RESULTS:We describe the rationale, specific aims, and design of the study. Alternative design considerations and extensive secondary aims and outcomes are discussed. CONCLUSIONS:XR-NTX is a potentially important treatment and relapse prevention option among persons with opioid dependence and CJS involvement. ClinicalTrials.gov: NCT00781898.
journal_name
Contemp Clin Trialsjournal_title
Contemporary clinical trialsauthors
Lee JD,Friedmann PD,Boney TY,Hoskinson RA Jr,McDonald R,Gordon M,Fishman M,Chen DT,Bonnie RJ,Kinlock TW,Nunes EV,Cornish JW,O'Brien CPdoi
10.1016/j.cct.2015.01.005subject
Has Abstractpub_date
2015-03-01 00:00:00pages
110-7eissn
1551-7144issn
1559-2030pii
S1551-7144(15)00006-3journal_volume
41pub_type
杂志文章,随机对照试验abstract：BACKGROUND:Despite evidence that palliative care increases quality and length of life, many patients and families remain uninformed about its nature and benefits. The purpose of this study is to test a psycho-educational intervention, Managing Cancer Care: A Personal Guide (MCC), intended to improve breast cancer patie...
journal_title：Contemporary clinical trials
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abstract：:Several randomized trials have found behavior change programs delivered via text messaging to be efficacious to improve preventive health behaviors such as physical activity and stopping smoking; however few have assessed its value in skin cancer prevention or early detection. The HealthyTexts study enrolled 678 parti...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
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abstract：:Patients with Parkinson's disease and related disorders (PDRD) and their families have considerable unmet needs including non-motor symptom management, caregiver support, spiritual wellbeing, advance care planning, and end-of-life care. There is increasing interest in applying palliative care (PC) models to better mee...
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abstract：OBJECTIVE:Our goal is to test the efficacy of a family-based, multi-component intervention focused on infants of African-American (AA) mothers and families, a minority population at elevated risk for pediatric obesity, versus a child safety attention-control group to promote healthy weight gain patterns during the firs...
journal_title：Contemporary clinical trials
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abstract：BACKGROUND:Patients with high blood pressure (BP) visit a physician an average of 4 times or more per year in the U.S., yet BP is controlled in fewer than half. Practical, robust and sustainable models are needed to improve BP in patients with uncontrolled hypertension. OBJECTIVES:The Home Blood Pressure Telemonitorin...
journal_title：Contemporary clinical trials
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abstract：BACKGROUND:With increased internet accessibility worldwide, it is now possible to assemble individuals with rare diseases through web-based patient registries. However, the validity of participant-reported medical diagnoses is unknown. The objective of this study was to evaluate the accuracy of participant-reported Neu...
journal_title：Contemporary clinical trials
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abstract：BACKGROUND:Cancer survivors suffer from long-term adverse effects that reduce health-related quality of life (QOL) and physical functioning, creating an urgent need to develop effective, durable, and disseminable interventions. Harvest for Health, a home-based vegetable gardening intervention, holds promise for these d...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
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abstract：UNLABELLED:Fatigue is a common and distressing symptom that can last for months or years in up to one-third of cancer survivors. Despite its prevalence, the nature and mechanisms of cancer-related fatigue are poorly understood and the available treatments may not provide sufficient relief. Fatigue has been identified a...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
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journal_title：Contemporary clinical trials
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journal_title：Contemporary clinical trials
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journal_title：Contemporary clinical trials
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journal_title：Contemporary clinical trials
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journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
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journal_title：Contemporary clinical trials
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journal_title：Contemporary clinical trials
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journal_title：Contemporary clinical trials
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journal_title：Contemporary clinical trials
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